Log in
RegisterAdverse Event [Study Performance]
posted by Helmut 
– Vienna, Austria, 2009-02-06 13:35 (6342 d 00:17 ago) – Posting: # 3190
Views: 4,886
Dear Neeraj,
there's no category like 'predose adverse event'. It's an AE, full stop (in one of our studies a volunteer was bitten by a dog in the washout - still that's an AE). The investigator should rate the relationship of the AE to the study medication. The rating scale hopefully is given in both the protocol and the CRF. IMHO most investigators would rate such an AE as 'unlikely'.
For examples of rating scales see this post.
there's no category like 'predose adverse event'. It's an AE, full stop (in one of our studies a volunteer was bitten by a dog in the washout - still that's an AE). The investigator should rate the relationship of the AE to the study medication. The rating scale hopefully is given in both the protocol and the CRF. IMHO most investigators would rate such an AE as 'unlikely'.
For examples of rating scales see this post.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Adverse Event Neeraj 2009-02-06 11:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adverse EventHelmut 2009-02-06 12:35
Ing. Helmut Schütz